In an era of increased concern over counterfeit and substandard products, theft and diversion, it is imperative that supply chains are secure. Mission-critical industries such as the pharmaceutical industry are being pressed into action to develop strategies and implementation plans to ensure compliance and uninterrupted supply.
One leading-edge solution that has figured prominently in anti-counterfeiting legislation is the application of randomly generated serial numbers at the lowest unit of sale (a.k.a. item-level serialization). Item-level serialization will co-exit with non-serialized information such as that contained within a universal product code (UPC). There are currently two prevailing methods of conveying serialized and non-serialized information: optically, or line-of-sight such as linear or two-dimensional barcodes and sightless technologies such as radio frequency identification (RFID).
In addition, the counterfeit drug problem has highlighted the importance of proper disposal of spent packaging materials. In the case of pharmaceuticals, where more than 3.8 billion prescriptions were filled in 2007 and valued in excess of $286 billion, branded and generic pharmaceutical manufacturers distributed more than 2.2 billion HDPE bottles. Most often, prescription drugs are sold to wholesalers and pharmacies in bulk quantities and are dispensed to patients in smaller, prescribed quantities. These bulk bottles are often tossed in the trash. For the enterprising counterfeiter, “dumpster diving” can yield a treasure trove of authentic bottles and labels that could be refilled with fake product and introduced back into the supply chain. Such practice has been proven to be the case in several counterfeit drug investigations conducted by the Food & Drug Administration's Office of Criminal Investigation (OCI).
This invention combines reading of data carriers to record serialized and non-serialized information, storing that information to a database and activating the destruction, or otherwise rendering of the of sensitive packaging materials unusable. Additionally, as in the case of highly regulated industries such as pharmaceuticals, the invention will take special care in its design; device installation and system integration to ensure the complete invention and the data it generates is compliant with various regulations including Title 21 CFR Part 11. Providing high quality data integrity will allow manufacturers of highly regulated products as in the case of pharmaceuticals to incorporate the data into their validated systems of record.